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24-hour Ambulatory Blood Pressure Monitoring in Patients With Blood Pressure Above Thresholds in General Practice

NCT ID: NCT03774147

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1067 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-12-31

Brief Summary

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High blood pressure (HBP) is a major modifiable cardiovascular risk factor which prevalence is gradually increasing. Reducing blood pressure (BP) significantly decreases cardiovascular morbi-mortality. Nevertheless, BP control remains insufficient: only 51% of French patients using antihypertensive drugs achieve the BP control targets.

HBP is mostly diagnosed and managed in primary care. Nevertheless, office BP measurements are unreliable for BP control and poorer predict target organ damage. Ambulatory BP measurements are recommended for HBP diagnosis and follow-up. 24-hour ambulatory blood pressure monitoring (ABPM) is the most cost-effective strategy. Its superiority has been demonstrated for HBP diagnosis and cardiovascular prognosis.

In France, ABPM is poorly available and little studied in primary care. Therefore, the investigators conducted a regional prospective study to analyze the feasibility and benefits of ABPM among primary care hypertensive patients in daily practice.

Detailed Description

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Conditions

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Hypertension Blood Pressure Monitoring, Ambulatory Primary Health Care

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients aged over 18 years
* with an office inclusion consultation systolic/diastolic BP≥ 140/90 mmHg
* able to understand French language and to consent to participate in the study

Exclusion Criteria

* patients aged \< 18 years
* with conditions preventing technically adequate ABPM (chronic atrial fibrillation)
* with contraindications to ABPM (musculotendinous disease of the upper limb, past history of phlebitis of the upper limb or phlebitis in progress, past history of olecranon bursitis or bursitis in progress)
* with previous ABPM in the 12 months prior to the inclusion consultation
* pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association pour le Développement de la Recherche en Médecine Générale (ADRMG)

UNKNOWN

Sponsor Role collaborator

Département de Médecine Générale de Dijon (DMG)

UNKNOWN

Sponsor Role collaborator

University of Burgundy

OTHER

Sponsor Role lead

Responsible Party

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Dr Claire ZABAWA

University senior registrar

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Groupements des Professionnels de Santé du Pays Beaunois

Beaune, , France

Site Status SUSPENDED

Maison Universitaire de Santé et de Soins Primaires

Chenôve, , France

Site Status RECRUITING

Cabinet de médecine générale

Garchizy, , France

Site Status SUSPENDED

Maison de santé de Terre Pleine

Guillon, , France

Site Status SUSPENDED

Maison de Santé Pluridisciplinaire

Montret, , France

Site Status RECRUITING

Groupement des Professionnels de Santé de l'Auxois Sud

Pouilly-en-Auxois, , France

Site Status RECRUITING

Maison de santé de l'Esplanade

Tournus, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Claire ZABAWA

Role: primary

Claire ZABAWA

Role: primary

Claire ZABAWA

Role: primary

Claire ZABAWA

Role: primary

Other Identifiers

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2014-A01536-41

Identifier Type: -

Identifier Source: org_study_id